Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Cisplatin; Etoposide

Criteria

Inclusion Criteria:

• Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation

• No previous systemic anticancer therapy

• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site

• ECOG Performance Status of 0 to 1

Exclusion Criteria:

• Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab

• Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)

• Known severe hypersensitivity to icotinib or any of the excipients of this product